FDA regulatory

Dosage form

Definition

The physical form in which a drug is supplied — tablet, capsule, injection, solution, kit and so on.

Dosage form drives the unit qualifier on a claim and often decides whether a drug is billable on the medical or the pharmacy benefit.

Route of administrationHow a drug enters the body — oral, intravenous, subcutaneous, intramuscular, ophthalmic and so on.Definition Unit qualifierA two-character code stating the unit in which the NDC quantity is expressed.Definition Kit (NDC)A single NDC covering a carton that contains more than one component, each of which may carry its own inner NDC.Definition

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